Cleared Traditional

K222979 - Microlife Upper Arm Automatic Digital B...

K222979 is the FDA 510(k) clearance for Microlife Upper Arm Automatic Digital B... by Microlife Intellectual Property GmbH. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K222979 · Microlife Intellectual Property GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
233d
Days
Class 2
Risk

K222979 is an FDA 510(k) clearance for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH (Widnau, CH). The FDA issued a Cleared decision on May 19, 2023 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Microlife Intellectual Property GmbH devices

Submission Details

510(k) Number K222979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2022
Decision Date May 19, 2023
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Mdi Consultants, Inc.
Vaibhav Arvind Rajal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K222979.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
K230075 · Microlife Intellectual Property GmbH · Jun 2023
Accurate 24 Non-invasive blood pressure monitor
K222658 · Accurate Meditech, Inc. · Jun 2023
Electronic Blood Pressure Monitor
K223291 · Shenzhen Pango Medical Electronics Co., Ltd. · Jun 2023
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
K222926 · Shenzhen Yuezhongxing Technology Co., Ltd. · May 2023
CONNEQT PULSE
K221742 · Atcor Medical · Apr 2023
Task Force CORE
K223332 · Cnsystems Medizintechnik GmbH · Apr 2023